Label: ZYCAZIN ANTISEPTIC LIQUID- camphor, phenol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 23, 2016

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  • Active ingredient

    Camphorated phenol (camphor 10.8% and phenol 4.7%)

  • Purposes

    Pain reliever/antiseptic

  • Uses

    • for temporary relief of pain associated with

    insect bites, minor burns, sunburn, minior cuts, scrapes, minor skin irritation, cold sores

    • first aid to help protect against infection in

    minor cuts, scrapes, minor burns

  • Warnings

    For external use only

  • Do not use

    • over large areas of the body
    • with a bandage
  • Ask a doctor before use if you have

    • a deep or puncture wound
    • animal bites
    • serious burns
  • When using this product

    do not use in or near the eyes. If contact occurs, rinse eyes thoroughly with water and obtain medical attention.

  • Stop use and ask a doctor if

    • condition worsens
    • symptoms persis for more than 7 days or clear up and occur again within a few days
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Do not induce vomiting before contacting medical help or a Poison Control Center.

  • Directions

    • adults and children 2 years and over:
    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • do not bandage
    • children under 2 years: ask a doctor
  • Other information

    • store at room temperature. Avoid excessive heat above 40°C (104°F).
    • close cap tightly after use
  • Inactive ingredients

    eucalyptus oil, light mineral oil

  • Questions or comments?

    1-888-742-9474 (Mon - Fri 9AM - 5PM EST) or www.zycazin.com

  • Carton

    Carton front Front of cartonBack of carton

  • INGREDIENTS AND APPEARANCE
    ZYCAZIN ANTISEPTIC LIQUID 
    camphor, phenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70351-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)10.8 mg  in 100 mL
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL4.7 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70351-101-121 in 1 CARTON11/01/2016
    112 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/01/2016
    Labeler - Axis Scientific LLC (057647986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Axis Scientific LLC057647986pack(70351-101) , manufacture(70351-101) , label(70351-101)
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